drugset / Trial / NCT03984448

Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas

NCT03984448

Phase 2/3 Active not recruiting 363 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II/III trial tests whether it is possible to decrease the chance of high-grade B-cell lymphomas returning or getting worse by adding a new drug, venetoclax to the usual combination of drugs used for treatment. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2. Drugs used in usual chemotherapy, such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with usual chemotherapy may work better than usual chemotherapy alone in treating patients with high-grade B-cell lymphomas, and may increase the chance of cancer going into remission and not returning.

Timeline

Start
2019-10-22
Primary completion
2028-04-01
Completion
2028-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Venetoclax Small molecule Oral
Background Cyclophosphamide Other / unclassified Intravenous
Comparator Doxorubicin Other / unclassified Intravenous
Background Etoposide Small molecule Intravenous
Background Prednisone Other / unclassified Oral
Background Rituximab Monoclonal antibody Intravenous
Background Vincristine Small molecule Intravenous